The BCG Replacement Vaccine VPM1002: From Drawing Board to Clinical Trial

Expert Rev Vaccines. 2014 May;13(5):619-30. doi: 10.1586/14760584.2014.905746. Epub 2014 Apr 7.


Tuberculosis remains a major health threat and vaccines better than bacillus Calmette-Guérin (BCG) are urgently required. Here we describe our experience with a recombinant BCG expressing listeriolysin and deficient in urease. This potential replacement vaccine has demonstrated superior efficacy and safety over BCG in Mycobacterium tuberculosis aerosol-challenged mice and was safe in numerous animal models including immune-deficient mice, guinea pigs, rabbits and nonhuman primates. Phase I clinical trials in adults in Germany and South Africa have proven safety and a current Phase IIa trial is under way to assess immunogenicity and safety in its target population, newborns in a high tuberculosis incidence setting, with promising early results. Second-generation candidates are being developed to improve safety and efficacy.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Animals
  • BCG Vaccine / administration & dosage*
  • Clinical Trials as Topic / trends*
  • Humans
  • Mycobacterium tuberculosis / drug effects*
  • Mycobacterium tuberculosis / physiology
  • Tuberculosis / epidemiology
  • Tuberculosis / prevention & control*


  • BCG Vaccine